Methods and devices for maintaining a space occupying device in a relatively fixed location within a stomach

ABSTRACT

Methods and devices for maintaining a space-occupying device in a fixed relationship relative to a patient&#39;s stomach by manipulation of the stomach. In one variation, two or more regions of the stomach wall are brought into approximation with one another and secured together in a manner that secures a space-occupying device within the stomach of the patient. In another variation, two or more regions of the stomach wall are wrapped around a space-occupying device to maintain the position of the space-occupying device relative to the stomach wall. In another variation, a system having a space-occupying member and a locking member capable holding the space-occupying member against the inner wall of the stomach are provided. In a further variation, a pouch is created within the stomach that receives and retains a space-occupying device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part and claims the benefitof earlier filed U.S. application Ser. No. 10/232,505, filed on Aug. 30,2002, which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

The present invention relates generally to methods and medicalapparatus, more particularly to methods and devices for securing the aspace-occupying devices in a patient's stomach through the manipulationof the inner wall of the stomach for purposes of taking up a definedvolume in the stomach to provide the patient with a feeling of satietyor fullness. These devices may also be removed once they have servedtheir purpose, e.g., the patient has lost the directed or desired amountof weight.

Currently, in cases of severe obesity, patients may undergo severaltypes of surgery either to tie off or staple portions of the large orsmall intestine or stomach, and/or to bypass portions of the same toreduce the amount of food desired by the patient, and the amountabsorbed by the intestinal track. Procedures such as laparoscopicbanding, where a device is used to “tie off” or constrict a portion ofthe stomach, or the placement of intragastric balloons can also achievethese results.

Endoscopic procedures that have been used to assist weight loss havebeen primarily focused on the placement of a balloon or other spaceoccupying device in the patient's stomach to fill portions of thestomach and provide the patient with the feeling of fullness, therebyreducing food intake. To accomplish these procedures, an endoscope isutilized to guide the balloon through the patient's mouth and down theesophagus to the stomach. Usually these procedures have allowedplacement of the device for 6-12 months, and are coupled withcounselling and other types of psychological support.

In the case of laparoscopic banding and other invasive surgicalprocedures, several complications can arise that make these proceduresclinically suboptimal. The surgical interventions require the patient tosubmit to an intervention under general anesthesia, and can requirelarge incisions and lengthy recovery time. In addition, most of thesesurgical procedures are irreversible.

Intragastric balloons, on the other hand, provide a minimally invasiveapproach for treating obesity. Intragastric balloons have been developedand used in patients for over twenty years. Prior to the presentinvention, various intragastric balloons have been devised for treatingobesity. Examples of such intragastric balloons are disclosed in U.S.Pat. No 4,133,315, issued Jan. 9, 1979 to Berman et al.; U.S. Pat. No.4,485,805, issued Dec. 4, 1984 to Foster, Jr.; U.S. Pat. No. 4,899,747,issued Feb. 13, 1990 to Garren et al.; U.S. Pat. No. 5,112,310, issuedMay 12, 1992 to Grobe; and U.S. Pat. No. 6,030,364, issued Feb. 29, 2000to Durgin et al; each of which is incorporated herein by reference inits entirety. However, many problems are associated with laparoscopicballoons and a significant number of these problems arose due to thefact that the space occupying devices were implanted in such a manner asto remain unattached or free-floating within the stomach. An unsecuredballoon could cause abrasion to the wall of the stomach, induce mucosaldamage, or stimulate abnormal amounts of acid production. Furthermore,in the event that the balloon deflates due to the caustic nature ofstomach acids and other factors, migration of the deflated balloon intothe intestine becomes inevitable. The migration of the balloon into theintestine could lead to bowel obstructions and in some case death.

In order to safely and effectively deploy balloons and otherspace-occupying devices in a patent's stomach to induce weight loss,improved methods and devices for effectively maintaining aspace-occupying device in a fixed relationship relative to the patient'sstomach are desirable.

BRIEF SUMMARY OF THE INVENTION

The present invention meets these and other needs by providing forimproved methods and apparatuses for securing a space-occupying devicewithin a patient's stomach by manipulating the wall of the stomach.Methods and apparatuses of the present invention may also be useful whenused in conjunction with existing procedures that result in manipulationof the stomach wall.

Minimally invasive surgical techniques, including but not limited totechnique used during a percutaneous endoscopic gastrostomy (PEG), maybe combined with methods discussed here for placement of space-occupyingdevices and at the same time minimize injury to the body. This inventionallows placement of space-occupying devices in a patient's stomach in astable and secured manner.

The space-occupying device may have a fixed volume and may be insertedinto the stomach through surgical procedures. However, it is preferablethat the space-occupying device is an inflatable or otherwise expandabledevice, and deliverable or otherwise deployable through the patient'smouth in a transesophageal procedure into the patient's stomach. Theexpandable space-occupying device may be constructed of a compositematerial to achieve desirable surface characteristics and may also bevisible under x-ray. In addition, the space-occupying device may havesurface features, such as a flange, beads, loops, and/or tabs tofacilitate manipulation, deflation and/or removal of the device. Thevolume of the space-occupying device may be adjustable while it ismaintained in the deployed c

In one aspect of the invention, an expandable device is provided thatcan be inserted into the stomach of a patient. Its position ismaintained within the stomach by manipulating the stomach wall about thedevice. The expandable device is secured on the wall of the stomach bywrapping a section of the stomach wall around a part of the device. Themethod may be achieved by securing one region of the stomach wall toanother region and at the same time partially encircling a section ofthe space-occupying device there by holding the space-occupying deviceto the wall of the stomach. The two regions of the stomach may besecured together with e.g. suture, or other like fasteners. However,more elaborate fastening devices may also be implemented for securingthe two regions of the stomach. It is preferable that the two regions ofthe stomach be brought into physical contact with one another, such thatthe approximated regions are able to fuse to one another and create atissue bridge along the length of the fastened tissue. The tissue bridgemay be formed of various layers of the stomach and may include scartissue and other elements of effective wound healing. An advantage ofsuch a method is that integrity of the stomach wall, especially themucosal layer, remains uncompromised, and exposure of the fastener tothe acidic conditions of the stomach is minimized. This is in contrastto other means of fastening a device to the stomach wall where thefastening means present a continuing potential trauma to the stomachwall and wherein such fastening means remain continually exposed tostomach acid.

In a variation of the method described above, the two regions of thestomach used to secure the space-occupying device are opposite eachother. A space-occupying device with an opening through its body may beanchored according to this method. The first region of the stomach isbrought through the opening on the device and into contact with thesecond region. A suture or other fastening device may be used to securethe two regions together. The space-occupying device implemented in thismethod may be e.g. toroidal or any other shape suitable for placementinside the stomach, provided the device contains an opening through thecenter of the device that provides a passageway from one side of thedevice to the other.

In another variation, multiple stomach regions may be approximated tosecure a space-occupying device. For example, three regions may be used,e.g. region one and two are secured onto region three or are otherwisebrought into approximation with each other. In an alternative variation,after the first set of surface areas are brought into approximation witheach other, additional surface areas on the inner wall of the stomachmay be brought into approximation of each other. For example, thespace-occupying device may be secured by two sets of approximatedsurface areas that secure the device at two different locations on thedevice.

In another aspect, the invention provides a space-occupying system orkit that consists of two portions, a sphere and a toroid. The spherewhen properly deployed acts as a “locking member” and in connection withthe toroid itself is able to maintain the toroid against the inner wallof the stomach. Procedures and methods for implementing such a system inthe stomach are also within the contemplation of this invention. In onevariation, a deflated toroidal shaped balloon is first deployed insidethe patient's stomach, and a region of the stomach wall is then forcedthrough the center opening of the toroidal balloon. A sphere is thendeployed from the external side of the stomach, passed through thecenter opening of the toroidal balloon and inserted within the sameregion of stomach tissue. The sphere has a diameter that is greater thanthat of the toroidal balloon center opening when the toroidal balloonitself is inflated. Thus, upon inflation of the toroidal balloon thesphere and associated region of stomach tissue is trapped against thetoroidal balloon, and cannot pass back through the center opening of theballoon, thus anchoring the toroid on the inner surface of the stomachwall. In the above procedure, it may also be possible to concurrentlypass the regions of stomach wall through the toroid along with thespherical locking member. Preferably, the regions of the stomach thatare trapped within the opening of the toroidal balloon are held inphysical contact with one another, such that the regions are able tofuse to one another and create a tissue bridge along the length of theapproximated regions. Such a tissue bridge has the advantages previouslydescribed.

In other variation of the dual-member-interlocking system for securing aspace-occupying device on the wall of the stomach, the space-occupyingdevice may be of various shapes suitable for placement inside apatient's stomach, and include an opening passing through the body ofthe space-occupying device. The corresponding locking member may beexpandable or of a fixed shape. The space-occupying device in itsdeflated state may allow the corresponding member to pass through itsopening. The space-occupying device is placed inside the patient'sstomach and the corresponding locking member is place inside thepatient's body, and outside the stomach. Through e.g. vacuum pull,physical pushing/pulling, or a combination of both, the locking memberis put through the opening of the space-occupying device. If necessary,the locking member may be expanded at this stage. The space-occupyingdevice is then inflated holding the locking member in its place.

In yet another aspect of the invention, methods are provided wherein apouch is created within the stomach that is able to receive and retain aspace-occupying device within the pouch. Such pouches can be createdaccording to known methods currently used to reduce stomach volume,including gastric bypasses, such as the Roux-En-Y gastric bypass,vertical banded gastroplasty (VBG), or laproscopic banding. Methods ofcreating a pouch capable of receiving and retaining a space-occupyingdevice also include those methods of plicating the stomach described inU.S. application Ser. No. 09/871,297, filed May 30, 2001, which iscommonly owned and incorporated herein by reference. Such plicationmethods include methods where transorally advanced tools are used toform a pouch or partition in the stomach by the approximation andfixation of folds of the stomach wall from inside the stomach. In onesuch exemplary procedure, folds in the posterior and anterior walls ofthe stomach are created using a tissue acquisition device inserted intothe stomach transorally, and then the two folds of tissue are fixedtogether thereby reducing stomach volume. The tissue folds may be fixedtogether in a variety of configurations. Space-occupying devices can bedeployed in the created pouches either initially to aid in the efficacyof the procedures, or post-procedure as a means, e.g., of enhancing theefficacy of such procedures.

In a further aspect of the invention, methods are provided wherein apouch is created within the stomach that is able to receive and retain aspace-occupying device within the pouch, and wherein the device isfurther designed to include a passageway extending through the deviceand a cavity within the device in communication with the passageway, thecavity further having a predefined volume. The device is introduced intothe pouch with the passageway in alignment with the esophagus so as toreceive and pass food. The cavity thus creates, in essence, a smallerartificial pouch within the originally created stomach pouch. Thisallows for convenient manipulation to optimize weight loss in a patientwithout the need of further interventional procedures, by simplyadjusting the cavity volume of the deployed device. This can be done,for example, by initially starting with a larger volume cavity device,monitoring the patient's progress, and transorally exchanging the devicefor one of sequentially smaller cavity volumes, until the desired weightloss parameters are achieved. Alternatively, the device can be providedwith a cavity volume that is adjustable. In particular, inflation orfilling ports are provided on the device that can be accessedtransorally, and the cavity volume can be adjusted by inflation ordeflation. In a further variation, the passageway and cavity of thedevice are relatively rigid as compared to the rest of the device,allowing for a slow, constant release of food unaffected by theperistaltic action of the stomach. In a further variation, the deviceincludes a sleeve extending from the passageway for the passage of fooddirectly through the pylorus and into the duodenum.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings, reference characters refer to the sameparts through out the different views. The drawings are intended forillustrating some of the principles of the invention and are notintended to limit the description in any way. Furthermore, the drawingsare not necessarily to scale, emphasis instead being placed uponillustrating the depicted principles in a clear manner.

FIG. 1 shows one variation of the method to anchor a space-occupyingdevice in the stomach according to the invention. Two regions of thestomach that are located across from each other in the stomach arebrought together at the opening in the center of the space-occupyingdevice and fastened to each other.

FIG. 2 illustrates an example of applying the method described in FIG. 1to maintain a toroidal space-occupying device at the upper portion of apatient's stomach.

FIG. 3 shows another embodiment of the inventive method wherein aspace-occupying device is secured in the stomach by a fastener thatsecures two separate regions of stomach wall together.

FIG. 4 illustrates an embodiment of a space-occupying device lockingsystem according to the invention. In this variation, the systemincludes an inflatable toroidal space-occupying device and an inflatablespherical locking member.

FIG. 5 is a cross-sectional view of a space-occupying device lockingsystem according to FIG. 4 deployed on the wall of a patient's stomach.The extragastric balloon is surrounded by a region of stomach wall thatinteracts with the toroidal intragastric balloon and prevents the twoballoons from moving.

FIG. 6 illustrates another aspect of the invention wherein aspace-occupying device is retained within a pouch created in the stomachthrough manipulation of the stomach wall. In the variation depicted, thestomach pouch has been created by performing a Roux-En-Y gastroplasty.

FIG. 7 illustrates a variation of the method shown in FIG. 6, where thepouch has been created by a vertical band gastroplasty.

FIG. 8 illustrates a variation of the method shown in FIG. 6, where thepouch has been created by laproscopic banding.

FIG. 9 illustrates a variation of the method shown in FIG. 6, where thepouch has been created by plication of the stomach.

FIG. 10 is a cross-sectional view of the stomach and space-occupyingdevice depicted in FIG. 9, showing the created pouch, stomach plicationline and the retained space-occupying device.

FIG. 11 is a sectional view of the stomach depicted in FIG. 9 takenalong the plane designated by lines 11-11 showing the plication of thestomach.

FIG. 12 illustrates yet another aspect of the invention wherein aspace-occupying device is retained within a pouch created in thestomach, the space-occupying device having a passageway and extendingsleeve configured to pass food from the patient's esophagus to thepylorus.

FIG. 13 illustrates a cross-sectional view the deployed space-occupyingdevice of FIG. 12 with parts broken away, showing a cavity within thedevice in communication with the passageway.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is focused on methods and devices for maintaininga space-occupying device in a relatively fixed position within apatient's stomach. Various methods and devices for deployment of aspace-occupying device in a human stomach that are well know to oneskilled in the art may be incorporated with the present methods anddevices in executing the procedure for deploying a space-occupyingdevice inside a patient's stomach and securing its location withinstomach. International Application No. PCT/US01/43868 (InternationalPublication No. WO 02/35980 A2) describes various tools, devices andmethods for deployment of expandable devices inside a patient's bodycavity. It is incorporated herein by reference in its entirety.

Referring to FIG. 1, one variation of the method according to thepresent invention of maintaining a space-occupying device 2 in a fixedrelationship to a patient's stomach is illustrated in detail. Thespace-occupying device 2 is adapted for occupying a defined amount ofspace within the stomach to provide the patient with a feeling offullness. The space-occupying device 2 is delivered into the patient'sstomach in the deflated state through a transesophageal procedure. Thespace-occupying device 2 is then inflated inside the patient's stomach.With the a of an endoscope, catheters and other surgical tools wellknown to one skilled in the art, a surgeon may place the space-occupyingdevice on the inner wall of the stomach. As shown in FIG. 1, the surgeonbrings together two regions 8, 10 of the stomach within an opening 4 onthe space-occupying device and secures the two regions 8, 10 to eachother. The two regions 8, 10 of the stomach to be brought together maybe located opposite one another. Although it is preferable that the tworegions 8, 10 be directly opposite each other, this not a necessaryrequirement in the application of this method and one skilled in the artwill appreciate that a variety of different region locations can be usedto achieve the desired result.

In the example illustrated in FIG. 1, the toroidal space-occupyingdevice 2 is secured in the stomach by fastening two regions 8, 10 of thestomach that are located on the opposite side of the stomach within thecenter passage way of the toroidal device. This may be achieved e.g. byfirst passing an elongated surgical instrument through the opening onthe toroid and then securing an area on the inner wall of the stomach.This first area of the stomach is then pulled through the toroidalopening. The first area of the stomach is then brought in contact with asecond area. At least one fastener 6 is then deployed to connect the twoareas 8, 10 of the stomach. FIG. 2 illustrates a toroidalspace-occupying device 2 secured at the upper portion of a patient'sstomach 14 with the method described above. The posterior and anteriorregions of the stomach that corresponds to the opening on the toroid arebrought together in the opening and fastened to each other.Alternatively, a space-occupying device 2 may also be placed in otherlocations within the stomach. For example, the space-occupying device 2may be positioned more towards the center of the stomach.

It is preferable, that the two regions 8, 10 of the stomach come incontact with each other. As illustrated in FIG. 3, the two regions 8, 10of the stomach may be brought into approximation and fastened to eachother with a fastener 6.

Furthermore, various fasteners 6 may be used to secure the two areas 8,10 of the stomach. It is preferable that the space-occupying devicedeployed in this manner has an opening 4 allowing the stomach tissue topass through it. However, the space-occupying device 2 may be of variousshapes one skilled in the arts considers suitable for deployment insidea patient's stomach.

Although it is preferable that the two regions 8, 10 of the stomachtissue that are brought together within the opening of thespace-occupying device be translated approximately the same distance, itis also within the contemplation of this invention that one region oftissue may be translated more than the other, resulting in the meetingpoint 7 or the gap 26 being shifted away from the center of thespace-occupying device toward one side or the other.

Alternatively, the space-occupying device 2 may be deflated or onlypartially inflated when it is being secured with the wall of thestomach. Once the space-occupying device is secured at the desiredposition, it is then fully inflated.

The two regions 8, 10 of the stomach may be fastened to each other withthe assistance of endoscopic instruments through the esophagus. Thefastener 6 may only partially penetrate the stomach wall withoutpenetrating the outer wall of the stomach.

Alternatively, sutures may also be used to secure the space-occupyingdevice that extend through the external wall of the stomach. Forexample, the space-occupying device is positioned in the stomach, aneedle with a suture the outside of the stomach through the wall of thestomach into the stomach. The surgeon then passes the needle through theopening on the space-occupying device and exits the stomach through thewall on the opposite side. The surgeon then brings the needle along withthe connected suture back into the stomach at approximately the sameregion and passing the opening again, and exits the stomach at alocation near the first entry point. The two ends of the sutured arethen secure to each other. As pressure is applied due to the tighteningof the suture, the two regions 8, 10 of the stomach collapse toward eachother and meet inside the opening within the space-occupying device.

In another variation, a laproscopic instrument can be used to deliver afastener through the stomach from extragastric space. The fastener isinserted into the abdomen and then through the anterior of the stomach.The fastener is then pushed through the opening of the space-occupyingdevice and through the stomach wall on the posterior side. An anchor isthen deployed, followed by application of pressure to force the two sideof the stomach to collapse toward each other. A second anchor is thendeployed on the opposite side of the stomach. The laproscopic instrumentis then withdrawn from the body of the patient leaving the fastener tosecuring the two region of the stomach. The result is similar to thesituation shown in FIG. 3, where anchors 24 are located outside thestomach, which have a large surface area relative to the entry and exitpoints of the fastener 6, and allow distribution of pressure from thefastener 6 over a larger area of the stomach tissue thus minimizingpotential damage to the tissue due to tearing or abrasion of the tissue.

In another variation, the stomach wall is wrapped around thespace-occupying device to maintain its position within the stomach. Thesurgeon may secure one region of the stomach wall and places it over thespace-occupying device. The surgeon then secures a second region of thestomach wall and places it over the space-occupying device. A fasteneris then used to secure the two regions of the stomach over thespace-occupying device. The fastener may be a suture, a surgical staple,a surgical clip, an implantable loop, or other devices commonly used insurgery for securing two sections of tissues together. As discussedearlier, the two regions of the stomach do not have to come in contactwith each other. It is sufficient that they are in approximation of eachother.

Although it is preferable that the two regions of the stomach tissuewrapping over the space-occupying device be approximately the sameamount, it is also within the contemplation of this invention that oneregion of tissue may be more than the other, resulting in the meetingpoint or the gap be shifted away from the center of the space occupyingdevice toward one side or the other.

Alternatively, the space-occupying device may be deflated or onlypartially inflated when it is being anchored to the wall of the stomach.After the space-occupying device is secured at the desired location thenit is fully inflated.

In the above method, other minimal invasive surgical techniques that arewell know to one skilled in the art may also be incorporated to assistthe positioning of the space-occupying device with the inner wall of thestomach. The surgeon may make incisions on the abdomen and introducecatheters and other laproscopic instruments into the stomach through theextra-gastric space. For example, the surgeon may insert an elongatedlaproscopic fastener instrument through the abdomen into the stomach.The fastener is then used to secure one region of the stomach wall,place it over an intragastric balloon, then position this first regionof the stomach wall over a second region of the stomach wall, and thendeploy a fastener to fasten the two regions of the stomach together.

Alternatively, the surgeon may introduce a needle connected to a sutureinto the abdomen of the patient and then penetrate the wall of thestomach with the needle at a first region and bring a section of thesuture into the stomach. The suture is brought over the space-occupyingdevice and exits the stomach at a second region. The needle thenpenetrates the stomach around the second region and enters the stomachagain. The needle and a section of the suture are then brought over thespace-occupying device and exit the stomach adjacent the first entrypoint. The suture is tightened and as the result forcing the two regionsof stomach tissue to collapse inward and wrapping around the spaceoccupying device.

The inflatable space-occupying device may be fabricated from medicalgrade rubber or synthetic rubber-like material, one criteria being thatsuch material be impervious so that the insert is capable of holding acharge of air or other fluid. Moreover, the material may be soft andflexible having significant dynamic strength to resist over-inflation.In one variation of the design, the finished product will inflate to themanufactured shape and not further. Polyester base thermoplasticpolyurethane film is one material that may be used to achieve suchfunctionality. In an alternative design, the inflatable space-occupyingdevice may be produced of flexible synthetic materials such aspolyethylene, polypropylene, PVC, PVCD, PET, teflon, polyolefin or anyother appropriate type of materials well known to one skilled in theart.

When the intragastric balloon is inflated, it may be desirable tocarefully control the inflation pressure so that when the balloon isdeployed the internal pressure is higher than average intragastricpressure during digestion to maintain shape, but less than maximalpressure generated by the stomach contractions, to minimize mucosaldamage.

The space-occupying device may be of various shapes that one skilled inthe art would consider suitable for placement inside the stomach of apatient. For example, in one variation, the space-occupying device mayhave an elongated bar shaped body with distal ends having largerdiameters than the mid-section of the device. This narrow mid-sectionallows easier wrapping of stomach tissue over the device and theexpanded ends prevent the device from shifting its position after it issecured with the stomach wall. Radio opaque markers may be incorporatedon the space-occupying device to assist physician in monitoring theposition and status of the space-occupying device while it is inside apatient's body. Alternatively, it may be desirable to coat thespace-occupying device with radio-opaque materials or other substancesthat may enhance the detection of the space-occupying device byelectronic monitors, e.g. x-ray monitor or ultrasound monitor, while thespace-occupying device is in the patient's stomach.

In another variation, the space-occupying device is secured with thewall of the stomach at two or more locations. For example, a toroidalshaped space-occupying device can be secured against the wall of thestomach at two separated positions on the toroid.

FIG. 4 shows yet another embodiment of the invention having aspace-occupying device 32 with an opening 34, in this case a toroidalintragastric balloon and a locking member 36, in this case sphericalextragastric balloon. The toroid 32 has a center opening with a diameter“d” when it is fully inflated. The sphere 36 has a diameter “D” when itis fully inflated. D is larger then d. Thus, when both the toroid 32 andthe sphere 36 are inflated the sphere 36 cannot pass through the opening34 of the toroid.

FIG. 5 illustrates the toroidal intragastric balloon 32 and thespherical extragastric balloon 36 being deployed on the wall of stomach40. A deflated toroidal (or doughnut shaped) intragastric balloon 32 isinserted into the stomach through the esophagus. A region 42 of thestomach wall is pulled into a fold or bag inside the stomach using e.g.a vacuum acquisition tool. The deflated toroidal intragastric balloon 32is positioned around the fold (or uvula). The spherical extragastricballoon 36 is then placed either laproscopically or gastroscopically(using transgastric deployment) inside the fold in the extragastricspace 44, and then inflated. The intragastric balloon 32 is theninflated and the two balloons become locked together across the gastricwall 40. Because the diameter of the inflated sphere 36 is larger thanthe diameter of the opening of the inflated toroid 32, there is amechanical interference between the two balloons that prevents the twoballoons from moving relative to one another or the stomach.

The balloons may be constructed of various materials that one skilled inthe art would consider suitable for fabrication of a balloon forimplantation inside a human body. For example, the intragastric andextragastric balloons may be fabricated from medical grade rubber orsynthetic polymeric materials. Flexible synthetic materials such aspolyurethane, polyethylene, polypropylene, PVC, PVCD, PET, teflon, theirmixtures and blocks or random copolymers may also be used.

Radio opaque makers may be incorporated in the space-occupying device 32and/or the locking member 36. The surface of the space-occupying deviceand/or the locking member may be coated with radio-opaque materials toenhance detection of the device while it is positioned in a patient'sstomach.

In an alternative design, the extragastric balloon 36 may be substitutedwith a viscous, curable bolus of a material such as collagen or otherbiocompatible polymer. The locking member may also be a solid componentsuch as delrin, silicon or titanium alloy ball. Other polymers or metalalloys may also be used to construct the locking member.

Although it is preferable that the intragastric balloon 32 be toroidalor doughnut shape, the intragastric balloon 32 may also have othershapes suitable for implantation inside a patient's stomach. In analternative design, the space-occupying device 32 is a non-inflatableobject with a relatively constant volume that is insert into a patient'sstomach through the esophagus or with surgical procedures. After theinsertion of the fixed-shape space-occupying device, an expandablelocking member 36 is used to anchor the space-occupying device on thewall of the stomach as described above.

Referring now to FIGS. 6-11, the present invention also contemplatesmethods of retaining space-occupying devices that rely on the creationof retaining pouches within the stomach through manipulation of thestomach or stomach wall. In current obesity treatments, the creation ofsuch pouches is the desired result of a variety of gastroplastyprocedures. The purpose of most of these procedures is to create asmaller, upper gastric pouch within the stomach, through manipulation ofthe stomach walls. As the smaller, upper gastric pouch expands orstretches upon intake of food, a feeling of early fullness is triggeredin the patient, which ideally results in reduced overall caloric intakeby the patient. According to methods of the present invention, thesepouches can also serve to receive and retain space occupying devices ofthe appropriate corresponding configurations. Due to the physicalconstraints of the pouches themselves, these space occupying devices aremaintained in place relative to the stomach as a whole and restrictedfrom migrating out of the pouch. The provision of a space occupyingdevice within a formed gastric pouch further lessens the amount of foodintake that will trigger a feeling of fullness in the patient. The spaceoccupying devices can be deployed at the time of the gastroplastyprocedure itself to enhance the efficacy of the gastroplasty. In otherscenarios, such as where a formed gastric pouch has become stretched outover time or has otherwise failed to provide the desired clinicaleffect, a space occupying device can be inserted at such later time toincrease or enhance the desired effect.

FIG. 6 in particular shows an upper, gastric pouch 54 formed from agastric bypass procedure commonly known as a Roux-en-Y gastric bypass(RYGB) procedure. In this procedure, the stomach is completely dividedinto two unequal portions, the smaller upper, gastric pouch 54 and alarger, lower gastric pouch 56, using e.g. an automatic stapling devicewith the raw surface being reinforced with additional sutures. The upperpouch typically measures less than about 1 ounce or 20 cc, while thelower larger pouch remains generally intact and continues to secretestomach juices flowing through the intestinal tract. Segment 57 of thesmall intestine (located just distal of the duodenum or proximal of thejejunum) is then brought from the lower abdomen and joined with theupper pouch 54 to form an end-to-end anastomosis 58 created through anopening or stoma of approximately one-half inch in upper pouch 54. Thissegment of the small intestine is called the “Roux loop” and carriesfood from the upper pouch to the remainder of the intestines, where thefood is digested. The remaining lower pouch 56 and the attached segmentof duodenum are then reconnected to form another anastomotic connection59 to the Roux loop at a location approximately 50-150 cm (1.6-4.9 ft.)from the stoma, typically using a stapling instrument. At thisconnection, the digestive juices from the bypassed stomach, pancreas,and liver enter the jejunum or ileum to aid in the digesting of food. Aswith other similar gastroplasty procedures, due to the small size of theupper pouch, patients are forced to eat at a slower rate and aresatiated much more quickly, thereby reducing the caloric intake.

Space-occupying device 52 is placed and maintained within upper gastricpouch 54 and further lessens the volume of pouch 54. Space-occupyingdevice 52 as depicted is spherical in shape but other configurations mayused that generally conform to the shape of the formed pouch. Thespace-occupying device can be formed of materials and deployed accordingto ways previously described herein.

FIG. 7 shows an upper, gastric pouch 64 formed from a vertical bandedgastroplasty (VBG) procedure. In this type of a procedure, upper gastricpouch 64 can be typically formed using a vertical staple line 67, withband 68 applied to prevent dilation of the outlet from upper pouch 64into the remaining portion of the stomach which forms lower pouch 66.Again, space occupying device 52 is placed and retained within upperpouch 64. Alternative methods of performing vertical banded gastroplastymay also be used, including those methods described in U.S. Pat. No.5,549,621, incorporated herein by reference.

FIG. 8 shows an upper gastric pouch 74 formed by a laproscopic bandingprocedure. In this type of a procedure, laproscopic methods and toolsare used to insert a banding device 78 that constricts the stomach wall,creating upper and lower gastric pouches 74 and 76, respectively. Spaceoccupying device 52 is deployed and retained within upper pouch 74.Variations on such laproscopic banding methods may also be used,including those methods described in U.S. Pat. No. 5,345,949,incorporated herein by reference.

FIGS. 9-11 show an upper gastric pouch 84 created by methods ofplication of the stomach wall. Preferred methods include those describedin U.S. application Ser. No. 09/871,297, filed May 30, 2001, which iscommonly owned and incorporated herein by reference. Such describedmethods include plication methods wherein transorally advanced tools areused to form a pouch or partition in the stomach by the approximationand fixation of folds of stomach. Referring to FIGS. 9-11, folds in theposterior wall 87 and anterior wall 89 of the stomach may be createdusing a tissue acquisition device inserted into the stomach transorally,and then the two folds of tissue may be fixed together using staples orother fastening means to create a linear segment or line of plicatedtissue 88. The plicated tissue runs at an angle relative to theesophogeal lumen, resulting in the formation of upper gastric pouch 84.Space occupying device 52 is received and retained with gastric pouch84. As can be seen, the plication of the anterior and posterior wallsdoes not extend across the entirety of the stomach, thereby leavingsmall openings 81 and 83 at either end of the plication for food to passinto the lower gastric pouch 86.

The above methods of retaining space-occupying devices in createdpouches can also be adapted for situations where it is difficult toperform a gastroplasty procedure, either by transoral stapling or othermethods previously described, at a more optimal location such as inclose proximity to the cardiac notch (or GE junction) of the stomach. Insuch situations, it may be advantageous to perform the stapling at amore accessible location, i.e., lower in the stomach from the cardiacnotch. In this scenario, the resultant pouch may have a volume on theorder of 150-200 ccs, as compared to more desirable volumes for optimalweight loss conditions of from 20-50 ccs. However, in such a situation,whether the larger pouch was created either purposefully orinadvertently, a larger space-occupying device commensurate in size withthe larger pouch can be selected and deployed according to the methodsdescribed herein.

FIGS. 12-13 illustrate one such application, where staple line 98 hasbeen placed at a lower position relative to the cardiac notch, therebycreating upper and lower pouches 94 and 96, respectively. Upper pouch 94has a larger relative volume as compared to upper pouches depicted inFIGS. 6-11. A space-occupying device, here depicted as intragastricballoon 102, is selected to have shape and commensurate volumeproportionate to that of upper pouch.

Referring now to FIG. 13, it can be seen that intragastric balloon 102is further provided with a passageway 104 extending through the balloonand a cavity 106 in communication with the passageway. The passageway isoriented such that it is aligned with the patient's esophagus. In thismanner, food can be received and travel through the passageway. In theinterior of the device, passageway 104 opens up into cavity 106 whichhas a defined volume. Cavity 106, in essence, defines an artificialpouch, that is smaller in volume than the originally created upperstomach pouch 94.

This system can be readily and conveniently manipulated by a physicianto adjust a patient's weight-loss treatment program without the need foradditional surgery. For example, a treating physician can initiallyplace a space-occupying device, such as intragastric balloon 102, thathas a relatively larger cavity volume. As the patient's weight lossprogress is monitored, the physician can as warranted, transorallyexchange the device with one having sequentially smaller cavity volumes,until the desired weight loss conditions, rate of loss, or otherparameters, are achieved. In this manner, the degree and pace of weightloss can be finely tuned, without need for additional invasiveprocedures.

Alternatively, intragastric balloon 102 can be constructed such that thevolume of cavity 106 is adjustable. For example, the device can beinflatable and further provided with an inflation or filling port orports (not shown) that are accessible to a transorally-advancedendoscope. Inflation media can then be introduced into or released fromthe balloon to alter the size of the cavity. Such adjustments could alsoaffect the overall volume of the balloon which can increase stretchingof the gastric pouch itself, further affecting weight loss.

In a further variation, passageway 104 and cavity 106 can be made to besomewhat rigid relative to the remaining components of the balloon. Insuch a variation, the exterior portions of the balloon will flex andexpand or contract to a much greater degree than the passageway. As aresult, the dimensions of the passageway and cavity remain fairlyconstant, and food that enters and fills the cavity will empty at aconstant rate and not be impacted by stretching and contraction of thestomach. In other words, the normal peristaltic effect of the stomach onfood contained in the passageway or cavity will be diminished. This mayslow the overall release of food from the device and further contributeto a more desired and controllable weight loss pattern in the patient.

As also shown in FIG. 12, intragastric balloon 102 further includes asleeve that extends from passageway 104. This sleeve can be positionedas shown to extend through pyloris and pyloric valve of the stomach andinto the duodenum of the small intestine. As shown in FIG. 13, thesleeve can be attached to the balloon by the provision of rim 105 whichis securable to corresponding recess 107 in passageway 104, although oneof ordinary skill in the art will recognize other known methods ofattachment. The provision of the sleeve allows food to pass directlyinto the small intestine and, depending on the overall length of thesleeve, can operate to avoid absorption of nutrients by the duodenumaltogether. Depending on the clinical situation, the inclusion of thebypass sleeve may be of further advantage.

This invention has been described and specific examples of the inventionhave been portrayed. The use of those specifics is not intended to limitthe invention in anyway. Additionally, to the extent there arevariations of the invention, which are within the spirit of thedisclosure or equivalent to the inventions found in the claims, it isour intent that this patent will cover those variations as well.

1-35. (canceled)
 36. A space-occupying device for placement andretention within a patient's stomach, the space occupying device havinga passageway extending through the device, and a cavity within thedevice and in communication with the passageway, the cavity having adefined volume, the device being deployable such that the passageway isoriented in alignment with the patient's esophagus.
 37. The device ofclaim 36 wherein the device further includes a sleeve extending from andin communication with the passageway and being deployable to extend pastthe patient's pylorus.
 38. The device of claim 36 wherein the passagewayand cavity are rigid.
 39. The device of claim 36 wherein the cavity isadjustable from a first defined volume to a second defined volume.
 40. Aspace-occupying device dimensioned for receipt and deployment within agastric pouch that has been created in patient's stomach through astomach volume reduction procedure, the device having a volumeproportional to that of the gastric pouch.
 41. The space-occupyingdevice of claim 40 wherein the volume of the device is less than thevolume of the gastric pouch.
 42. The space-occupying device of claim 40wherein the volume of the device is 200 cc or less.
 43. Thespace-occupying device of claim 40 wherein the volume of the device is150 cc or less.
 44. The space-occupying device of claim 40 wherein thevolume of the device is 50 cc or less.
 45. The space-occupying device ofclaim 40 wherein the device is further adapted for fastening to thepatient's stomach wall.
 46. The space-occupying device of claim 40wherein the device has a toroidal shape.
 47. The space-occupying deviceof claim 40 wherein the device is inflatable.
 48. The space-occupyingdevice of claim 40 wherein the device is an intragastric balloon. 49.The space-occupying device of claim 40 the device having a passagewayextending through the device, and a cavity within the device and incommunication with the passageway, the cavity having a defined volume,the device being deployable such that the passageway is oriented inalignment with the patient's esophagus.
 50. The device of claim 49wherein the device further includes a sleeve extending from and incommunication with the passageway and being deployable to extend pastthe patient's pylorus.
 51. The device of clans 49 wherein the passagewayand cavity are rigid.
 52. The device of claim 49 wherein the cavity isadjustable from a first defined volume to a second defined volume.
 53. Amethod of maintaining a space-occupying device within a patient'sstomach comprising the step of introducing a space-occupying deviceaccording to any one of claims 40-52 into a gastric pouch that has beencreated in patient's stomach through a stomach volume reductionprocedure.